Kornimate/medical-research-clean huggingface dataset:
great auricular nerve block for children undergoing tympanomastoid surgery

Conditions: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma

Summary: the investigators goal is to determine the efficacy and duration of analgesia with the addition of clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.

the surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. no prophylactic dexamethasone or ondansetron would be provided to any patients in either group. anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the chipps (children and infants postoperative pain scale). if two consecutive pain scores at 5 minute intervals is \>6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of \<6. the number of rescue doses as well as the pain scores will be documented. these patients will be also observed for the presence of nausea/vomiting. any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. all patients will be continued to be evaluated in the 23 hour unit. pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. the number of doses of acetaminophen with codeine will be recorded. time to discharge from the hospital will also be noted. a questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. the use of any additional rescue pain medication will be provided to the families at the time of discharge. a follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.

Eligibility criteria:
inclusion criteria: * age 1-18 years * tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery) * asa i, ii * informed consent and assent obtained exclusion criteria: * allergic to local anesthestic * taking chronic aspirin or ibuprofen therapy * asa iv * history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions * patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease. * informed consent not obtained * patients expected to receive dexamethasone or ondansetron intra-operative

Keywords: tympanomastoid surgery cochlear implant mastoidectomy cholesteatoma pediatrics clonidine bupivacaine greater auricular nerve block regional anesthesia
dahanca 19: the importance of the egfr-inhibitor zalutumumab for the outcome after curative radiotherapy for hnscc

Conditions: Cancer of the Head and Neck

Summary: the purpose of this study is to determine whether the addition of the fully human egfr antibody zalutumumab to primary curative radiotherapy increases locoregional control in squamous cell carcinomas of the head and neck.

radiotherapy to squamous cell carcinomas of the head and neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. by these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity. the addition of antibodies against the epidermal growth factor receptor (egfr-i) may further increase the control and survival of patients with squamous cell carcinomas of the head and neck when combined with radiotherapy and/or chemotherapy. the aim of the present study is to determine whether 1. the addition af the egfr-i zalutumumab increases locoregional control in squamous cell carcinomas of the head and neck 2. whether disease-specific survival or overall survival is improved by addition of zalutumumab 3. whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable 4. acute and late toxicity to the treatment.

Eligibility criteria:
inclusion criteria: * histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx) * curative intent and no prior treatment * age \> 18 years * who performance 0-2 (incl.) * no prior treatment with egfr-i * informed consent according to local guidelines and national law * the patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up * fertile women must use contraceptive devices (iud or oral contraceptives) exclusion criteria: * rhinopharynx or carcinomas of unknown origin * distal metastases * other malignant diseases (prior or current) except from planocellular skin cancer

Keywords: squamous cell carcinomas of the head and neck epidermal growth factor receptor antibody radiotherapy
phenotypical characterization of peanut allergic children

Conditions: Nut Hypersensitivity; Child; Legumes Allergy; Tree Nut Allergy; Allergy Cross Reaction

Summary: peanut allergy (pa) has been well studied and its prevalence was estimated up to 1.3% in europe. tree nut (tn) allergy and pa are clinically similar and often coexist, tn allergy prevalence ranged from 0.05 to 4.9 %. tn allergy is longlasting and nearly all tn have been associated with fatal allergic reactions . other legumes or tn also contain seed storage protein orthologs of the globulins (ara h1, ara h 3) and 2s albumins (ara h 2) of peanut, susceptible to provoke allergic reactions, but cross-reactivity to tn and other legumes in pa patients could also appear through primarily sensitization. these possible ige-binding cross-reactions bring to recommend the avoidance of tn and other legumes which have never been eaten in pa children. in this context, diagnosis work-up of relevant cross-allergy versus asymptomatic cross-sensitization will impact directly children's health-related quality of life (hrql). when physicians suspect food allergy, many parameters have to be considered, such as clinical background, clinical history, type of symptoms related to the suspected food and cross-allergy to other foods. then, to objectively confirm a food allergy and to assess its severity (related to the threshold reactive dose and symptoms), an oral food challenge (ofc) is demanded, and double-blind placebo-controlled food challenge (dbpcfc) is considered as "the gold standard". although ofc are more and more available in the diagnosis of pa, the assessment of cross-allergy to every single allergenic tn and legumes requires full allergy work-up and often many years of follow-up. few studies investigated cross-allergy to tn and other legume, with rates of cross-allergy to tn between 28% and 50%. however, targeting patients with severe or cross-allergic phenotypes would greatly assist the allergist in management and follow-up of pa patients (i.e., planning ofc to cross-reactive food). our main objective is to identify different disease phenotypes of pa children with cluster analysis. this statistical approach has never been performed to identify cross-allergic phenotypes. we also will describe cross-allergy in pa and will identify possible risk factors for cross-allergy to tn and other legumes in pa children.


Eligibility criteria:
inclusion criteria: * child evaluated at the allergy unit of saint vincent hospital of lille (france) from march 2004 to may 2016 * peanut allergy proven with a double-blind placebo-controlled food challenge exclusion criteria: * patients who had incomplete evaluation for major peanut component at the time of their double-blind placebo-controlled food challenge to peanut. * all patients refusing oral food challenge.
the fasting and shifted timing (fast) of eating study

Conditions: Overweight and Obesity

Summary: the aim of this study is to assess peoples' satisfaction with their diet based on adhering to three different meal-timing protocols for one week each: (1) time-restricted feeding (trf); (2) intermittent fasting (if); and (3) alternate day fasting (adf). the overall goal of this study is to determine if people would find it easy or difficult to follow these diet protocols for the purpose of weight management.

fasting and time-restricted feeding (trf) have become increasingly popular in nutrition research due to the potential health benefits they may provide. several animal studies, and more recently some human studies, have indicated regular meal-timing (i.e. eating mostly in the day) or fasting have been beneficial for controlling weight, blood pressure, cholesterol, glucose, and insulin sensitivity. these types of eating patterns may offer the same "anti-aging" health benefits as traditional caloric restriction (i.e. consistent and routine adherence to a very low-calorie diet).while caloric restriction is considered the gold standard for weight management, weight regain often limits the long-term effectiveness of this approach. people often experience increases in hunger, which make it difficult to sustain this type of behavior.therefore, researchers are turning to these dietary approaches as alternatives to low-calorie diets in an effort to obtain the same benefits, but with less burden on participants. however, it is not clear if the adherence to these types of diet protocols are any better than a low-calorie diet. would people be more satisfied with meal-timing or fasting over a traditional very low-calorie diet? that is the main research question of this study.

Eligibility criteria:
inclusion criteria: * be 18 years or older. * have a bmi between 25 - 49.9 kg/m2. * have a scale at home, or some way of weighing yourself regularly, so that you can report your body weight to the research staff. * be able to check emails regularly, because all of the surveys need to be completed online. exclusion criteria: * not be already practicing any of these fasting approaches. * not currently diagnosed with diabetes. * not taking any appetite suppressants or prescription weight loss medications. * not planning on getting pregnant within the next 6 weeks. * do not currently have any eating disorders. * have not lost or gained a significant amount of weight (i.e. 10 pounds or more) within the last 6 months.

Keywords: fasting
small hyperplastic and adenomatous reliability protocol

Conditions: Adenomatous Polyp

Summary: 1. protocol summary title: sharp: small hyperplastic and adenomatous reliability protocol purpose: to compare the accuracy of nbi-in vivo differentiation between hyperplastic and adenomatous \<10 mm polyps with that of histology in an european multi-center study. to assess variability among endoscopists in nbi accuracy. we also aim to assess whether this technology impacts the appropriateness of surveillance intervals. design: 1) before starting the patient enrollment, the participating endoscopists will attend an internet-based training program on the in vivo differentiation between hyperplastic and adenomatous polyps. following this course, a qualifying examination will be required for each endoscopist to be included. 2) patients who are scheduled for screening or diagnostic colonoscopy will be considered for inclusion. patients with at least one histologically verified \<10 mm polyp will be included. in order to measure nbi feasibility, each included polyp will be in vivo assessed by nbi in order to rank between a high- and a low- level of diagnostic confidence, and thereafter will be sent for histological assessment. nbi- and histological accuracy in differentiating between hyperplastic and adenomatous lesions will be analyzed and compared, in order to assess the nbi-sensitivity and specificity. the primary outcomes are to measure the nbi feasibility and accuracy in the study population, and to assess the variability among the endoscopists. secondary outcome measures will be a cost analysis on how much savings would be achieved by not referring nbi-diagnosed hyperplastic polyps to histology, and a clinical inference on how many patients would be scheduled for an inappropriate post-polypectomy follow up, when follow up schedule is based on nbi classification. clinical results will be analyzed using various statistical measures of significance. clinical site locations: 10 european centres with nbi-technology 1 nbi-expert endoscopist for each centre enrollment: 160 small (\<10 mm) polyps at each site study technology: nbi-olympus without optical magnification risk: non-interventional study.


Eligibility criteria:
inclusion criteria: * 1. the patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. the patient is at satisfactory risk to undergo abdominal surgery; 3. the patient must understand and provide written consent for the procedure. exclusion criteria: * 1. the patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. the patient is at satisfactory risk to undergo abdominal surgery; 3. the patient must understand and provide written consent for the procedure.

Keywords: colonoscopy, narrow-band imaging
feasibility of a method for analysis of alzheimer´s disease specific proteins in nasal secretion

Conditions: Nasal Secretion; Alzheimer Disease; Brain Nose Interface

Summary: this study is a first in man study investigating the feasibility of the collection, storage, processing and analysis of 4 key biomarkers for the diagnosis of alzheimer's disease \[ad\] in nasal secretion. nasal secretion \[ns\] constitutes a minimally invasive access to cerebrospinal fluid \[csf\]. therefore, it could be highly suitable for detection and monitoring of the ad relevant biomarkers ptau181, total tau, amyloid-ß1-40 and amyloid-ß1-42. this study evaluates correlations of biomarker patterns in ns and csf. furthermore, the correlations of the 4 ad specific biomarkers in nasal secretion and csf is investigated. for this study, patients with cognitive impairment (ad and nonad group) and healthy controls were included.


Eligibility criteria:
inclusion criteria: * group a patient with cognitive impairment and no nasal pathologies. csf analysis is planned or results are already available * group b patient without cognitive disorder and without pathologies in the nasal area exclusion criteria: * presence of an obstructing nasal cavity disease * patient suffers from an acute upper respiratory tract infection (putrid rhinorrhea) * inability to give consent
an extension study to evaluate the long-term efficacy, safety and tolerability of minzasolmin (ucb0599) in study participants with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (ucb0599) on brain pathophysiology in early-start versus delayed-start participants originally diagnosed with new onset parkinson's disease.


Eligibility criteria:
inclusion criteria * participant completed the treatment period of pd0053 (nct04658186). the baseline visit for pd0055 (visit 2) should be no later than 4 weeks following the end of treatment (eot) visit in pd0053 (nct04658186). any delay needs to be justified by the investigator and approved by the sponsor * a male study participant must agree to use contraception during the treatment period and for at least 90 days after the last dose of the imp and refrain from donating sperm during this period. * a female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: ◦ not a woman of childbearing potential (wocbp) or a wocbp who agrees to follow the contraceptive guidance during the treatment period and for at least 1 month after the last dose of investigational medicinal product (imp). the study participant must have a negative urine pregnancy test at screening (visit 1), which is to be confirmed negative by urine testing prior to the first dose of imp at pd0055 baseline visit. if oral contraception is used, an additional barrier method will be required during the study as an imp-related gastrointestinal upset or a drug interaction by cytochrome p450 3a4 (cyp3a4) induction could interfere with efficacy * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * study participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study * a female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding * study participant had previously participated in pd0055 * study participant meets any withdrawal criteria in pd0053 (nct04658186) * study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using digital health technology, but may participate in the main study * study participant does not agree to refrain from donating blood or blood products or other body fluids

Keywords: parkinson's disease. ucb0599 phase 2 minzasolmin
the impact of snap-ed among bhutanese adults residing in new hampshire

Conditions: Supplemental Nutrition Assistance Program Education; Bhutanese Refugee Adults

Summary: the goal of this pilot randomized controlled trial is to test the potential efficacy of supplemental nutrition assistance program education (snap-ed) among bhutanese refugee adults residing in new hampshire. the main questions are whether direct snap-ed delivered through 6 lessons affects dietary quality and biomarkers of metabolic risk. participants in the snap-ed arm will be asked to participate in weekly lessons delivered in their homes by a bicultural and bilingual nutrition educator. individuals in the control group did not receive snap-ed. all participants will be asked to complete surveys and provide blood and fecal samples prior at baseline and at the end of the study period (7 to 8 weeks).


Eligibility criteria:
inclusion criteria are (1) identifies as a bhutanese refugee (2) 18 years and older (3) does most of the cooking and shopping for his/her household. exclusion criteria are (1) has been told by her/his doctor that she/he has diabetes (2) history of use of glucose lowering medications (3) pregnant or trying to become pregnant (4) currently diets for weight loss or dietary restrictions.
outcomes for versawrap in achilles tendon repair

Conditions: Achilles Tendon Injury

Summary: the purpose of this study is to evaluate the efficacy on the use of versawrap® in surgery of the foot and ankle. versawrap is designed to allow tendon gliding and to protect tendon gliding postoperatively

this is a prospective, multi-center, controlled case series evaluating the use of versawrap in surgeries of the foot and ankle. patients identified by the investigator in his practice as needing surgery for an achilles primary or elective insertional repair and meeting all the inclusion and none of the exclusion. patients will consent to participating in the study, prior to any study procedures.

Eligibility criteria:
inclusion criteria: 1. patients that require surgery for achilles primary or elective insertional repair. note: primary repair must be conducted within 6 weeks of injury. additional repairs may be conducted during surgery, confirm with study sponsor prior to enrollment. insertional repairs due to trauma are not eligible. 2. able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol 3. age ≥18 years and \<90 years at the time of surgery exclusion criteria: 1. investigator determines that the subject is unlikely to comply with the requirements of the study 2. active systemic infection or infection at the location planned surgery 3. uncontrolled diabetes 4. prior achilles surgery on either ankle 5. active or suspected malignancy. if symptom free for 2 years, patients with prior malignancy may be included 6. morbid obesity defined as a body mass index \> 40 7. pregnant or have plans to become pregnant in the next year 8. currently a prisoner 9. autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis) 10. medications that could interfere with fusion or other bone/soft tissue healing (e.g., anticipated continued use of systemic steroid medication postoperatively)
clinical characterization on pde6a-related retinitis pigmentosa in preparation to a gene therapy trial

Conditions: Retinitis Pigmentosa

Summary: mutations in the pde6a gene - encoding the -subunit of the rod cgmp-phosphodiesterase - account for 1% of autosomal recessive retinitis pigmentosa (arrp) through impaired regulation of cgmp levels in the rod outer segment. this study aims for a detailed clinical characterization of patients with pde6a mutations in preparation of a clinical gene replacement study (phase i/ii safety trial).

retinitis pigmentosa (rp) is a clinically and genetically heterogenous group of hereditary retinal disorders, being one of the most common types of retinal degenerations with a prevalence of 1:4000. more than 45 genes have been associated with rp so far, whose defects cause a progressive loss of rod photoreceptor function, followed by cone photoreceptor dysfunction often leading to complete blindness. mutations in the pde6a gene - encoding the -subunit of the rod cgmp-phosphodiesterase - account for 1% of autosomal recessive retinitis pigmentosa (arrp) through impaired regulation of cgmp levels in the rod outer segment. with the help of improved genetic and functional diagnostic tools an early recognition and differentiation has become possible. still, up to date no established therapy is available, therefore, social and professional consequences are essential tasks to deal with. the modern ophthalmological functional diagnostic tools enable a precise characterisation and early recognition of such retinal diseases. the detailed results and information can help to extend the understanding of the pathological mechanisms involved in these diseases. in this study the investigators intend to investigate patients with a genetically confirmed diagnosis of retinitis pigmentosa due to pde6a mutations hereby assessing the function and structure of the retina with an extensive battery of tests.

Eligibility criteria:
inclusion criteria: * retinitis pigmentosa patients with genetically confirmed mutations in the pde6a-gene * written informed consent exclusion criteria: * severe general disease, that would make longer examinations not possible * patients who cannot give written informed consent independently

Keywords: retinitis pigmentosa pde6a gene therapy trial